Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trials

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Combining L-theanine and Paraxanthine for Transient Improvement of Cognitive Deficits Among Patients With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder: A Series of Translational Pilot Neuroimaging Studies

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This pilot study will test whether combining L-theanine and paraxanthine improves sustained attention, inhibitory control, and overall cognition in adults with ADHD and ASD. Two parallel randomized, single-blinded, repeated-measures crossover trials will be conducted. Participants will complete neuropsychological testing, fMRI scanning, and self-report measures following administration of the L-theanine-paraxanthine combination compared to placebo.

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

• Adults (18+ years) diagnosed by a physician (per self-report) with ADHD or ASD

• \* Participants with a dual diagnosis and ASD and ADHD will be recruited but will only be included in the ASD group - their concurrent ADHD diagnosis will be included as an additional variable in exploratory analyses

Locations
United States
Texas
Texas Tech University
RECRUITING
Lubbock
Contact Information
Primary
Chathurika S Dhanasekara, MD, PhD
samudani.dhanasekara@ttuhsc.edu
806-743-2378
Backup
Chanaka N Kahathuduwa, MD, PhD
chanaka.kahathuduwa@ttuhsc.edu
806-412-9974
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 24
Treatments
Experimental: Attention deficit hyperactivity disorder (ADHD)
A group of 12 adult males with Attention Deficit Hyperactivity Disorder (ADHD) will be enrolled. Each participant will receive both study conditions in a randomized, single-blinded, repeated-measures crossover design:~Active Condition: One capsule containing 200 mg L-theanine + 200 mg paraxanthine.~Placebo Condition: One capsule containing 400 mg of corn starch. The order of administration will be randomized, with each participant completing both conditions on separate visits (visits 2 and 3).
Experimental: Autism spectrum disorder (ASD)
A group of 12 adult males with autism spectrum disorder (ASD) will be enrolled. Each participant will receive both study conditions in a randomized, single-blinded, repeated-measures crossover design:~Active Condition: One capsule containing 200 mg L-theanine + 200 mg paraxanthine.~Placebo Condition: One capsule containing 400 mg of corn starch. The order of administration will be randomized, with each participant completing both conditions on separate visits (visits 2 and 3).
Sponsors
Collaborators: Texas Tech University
Leads: Texas Tech University Health Sciences Center

This content was sourced from clinicaltrials.gov